MAUDE Adverse Event Report: ATRICURE, INC. CRYOICE CRYOSPHERE CRYO-ABLATION PROBE

Model Number	CRYOS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cryogenic Burn (4539)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the cryos device was returned for evaluation and visually and functionally tested.The complaint could not be confirmed as cryos device met operating specifications.
Event or Problem Description
On (b)(6) 2022 that a male patient underwent an off-pump, nuss / cryo-nerve block (cnb) procedure.During the cnb, the physician noticed an area of frostbite on the patient's skin.The impacted skin was excised.Post procedure, patient was doing well.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: CRYOICE CRYOSPHERE CRYO-ABLATION PROBE
• Common Device Name: CRYOICE CRYOSPHERE CRYO-ABLATION PROBE
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 15331399
• Report Number: 3011706110-2022-00030
• Device Sequence Number: 5340033
• Product Code: GXH
• UDI-Device Identifier: 30840143902912
• UDI-Public: (01)30840143902912(17)250101(10)116705
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K180138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2025
• Device Model Number: CRYOS
• Device Catalogue Number: A001009
• Device Lot Number: 116705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male