| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CRYOICE CRYO-ABLATION PROBE | CRYOICE CRYO-ABLATION PROBE | ATRICURE, INC. | GXH | CROY2 | A000683 | UNKNOWN | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-02-26 | 0 | 1. S |
Patient 1
(B)(4) THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT CRYO2 LOT NUMBER WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED. THERE WAS NO REPORTED DEVICE MALFUNCTION OR PROCEDURE COMPLICATION.
Patient 1
ON 1/29/2018 DURING A CONVERSATION BETWEEN THE SALES REP AND A SURGEON, THE SURGEON STATED THAT A PATIENT REPORTED ABDOMINAL BULGING SHOWING UP SHORTLY FOLLOWING A VATS LOBECTOMY PROCEDURE WITH CRYOA WHERE THE CRYO2 CRYO-ABLATION PROBE WAS USED. THE PATIENT REPORTED THE ADVERSE EVENT DURING THE 30 DAY FOLLOW UP VISIT AND THE SURGEON NOTED AN ASYMMETRY OF THE ABDOMINAL WALL ON THE SIDE IN WHICH HE CRYOABLATED WITH THE CRYO2 DEVICE. IT FIRST PRESENTED AS ABDOMINAL MUSCLE BULGING WHICH HE THOUGHT WOULD RECOVER FOLLOWING NERVE REGENERATION, BY THE NEXT FOLLOW UP VISIT WHICH WAS AT 18 MONTHS, IT WAS NOTED THAT THE ABDOMINAL WALL DID NOT RECOVER. HE THOUGHT IT WAS COMING FROM CRYOABLATING LEVELS 9, 10, AND 11. HE HAS NOW RESORTED TO CRYOABLATING ABOVE THE 9TH INTERCOSTAL SPACES ONLY. THE CURRENT CONDITION OF THE PATIENT IS PERSISTENT MUSCLE BULGING OF THE ABDOMINAL WALL ON CRYOABLATION SIDE OF CHEST WALL FOLLOWING LUNG SURGERY. IT WAS REPORTED THAT THIS WAS NOT A PAINFUL COMPLAINT AND DID NOT NECESSITATE ANY TYPE OF PAIN TREATMENT, IT WAS MORE OF A COSMETIC COMPLAINT.