# K160994: C2 CryoBalloon Focal Pear Catheter

- Pathway: 510(k) (Special)
- Applicant: C2 Therapeutics, Inc.
- Decided: May 19, 2016 after 41 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K840536 (1984). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131523: Cryoballoon Focal Ablation System, C2 Therapeutics (2013) Summary page 4.

## Indications for use
The C2 CryoBalloon™ Focal Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Source page: https://510kreport.com/device/K160994
Methodology: https://510kreport.com/methodology