Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 22, 2017
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus wit
The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Control…
C2 Therapeutics, Inc. recalled C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical… - a moderate-severity action.
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical… was recalled by C2 Therapeutics, Inc. in March 22, 2017. Reason: The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. T…. Check the official notice for the remedy. Verify recall #Z-1477-2017 with the FDA Devices before acting.
The recall
C2 Therapeutics, Inc. issued this moderate-severity FDA Devices recall-The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. T….
- Moderate
- severity level
- Class II
- classification
- March 22, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1477-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1477-2017) was formally reported on March 22, 2017, with the manufacturer initiating the action on January 6, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. C2 Therapeutics, Inc. is listed as the recalling firm, operating out of Redwood City, CA. Federal records list the affected scope as 755 controller caps.
The documented reason for this recall is: The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
755 controller caps
Related Recalls
6
3 from same agency
Product description
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
Reason for recall
The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1477-2017 |
| Date reported | March 22, 2017 |
| Date initiated | January 6, 2017 |
| Recalling firm | C2 Therapeutics, Inc. |
| Firm location | Redwood City, CA |
| Affected scope | 755 controller caps |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1477-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.. Recalled by C2 Therapeutics, Inc.. Units affected: 755 controller caps.
Why was this product recalled? ▼
The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2017. Severity: Moderate. Recall number: Z-1477-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1477-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 22, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.