Ablation systems
C2 CryoBalloon Full 8 Catheter
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
C2 CryoBalloon Full 8 Catheter models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| FG-1032 | — | Not stated | Available |
FDA clearances
- 510(k) K153541 January 2016
Procedures that use ablation systems
Frequently asked questions
What is C2 CryoBalloon Full 8 Catheter used for?
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
Who makes C2 CryoBalloon Full 8 Catheter?
C2 CryoBalloon Full 8 Catheter is made by C2 Therapeutics, Inc.. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does C2 CryoBalloon Full 8 Catheter come in?
The FDA device database does not list sizes for C2 CryoBalloon Full 8 Catheter. Check the instructions for use or ask a C2 Therapeutics, Inc. representative.
Is C2 CryoBalloon Full 8 Catheter MRI safe?
The FDA device database entry for C2 CryoBalloon Full 8 Catheter does not state its MRI safety status. Check the labeling before MRI.
Is C2 CryoBalloon Full 8 Catheter FDA cleared?
C2 CryoBalloon Full 8 Catheter is covered by FDA submission K153541.
How do I contact a C2 Therapeutics, Inc. sales representative?
C2 Therapeutics, Inc. has not listed representatives on LA Vascular yet. Visit the C2 Therapeutics, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.