MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE CRYOICE CRYOABLATION SYSTEM (CRYO2); DEVICE, SURGICAL, CRYOGENIC

Model Number	CRYO2
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with cad (coronary artery disease) and new onset of sob (shortness of breath).Procedure: cabg x 2 (coronary artery bypass graft), mitral valve replacement, maze and left atrial appendage occlusion.The probe was inside the patient and did not freeze when used.It was removed from the patient and attempted to reactivate outside the body and would not freeze.A new one obtained and froze without issues.No known harm to patient- delay in procedure.Manufacturer response for device, surgical, cryogenic, atricure cryoice cryoablation system (cryo2) (per site reporter): will obtain.

• Brand Name: ATRICURE CRYOICE CRYOABLATION SYSTEM (CRYO2)
• Common Device Name: DEVICE, SURGICAL, CRYOGENIC
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 17142629
• Report Number: 17142629
• Device Sequence Number: 11239683
• Product Code: GXH
• UDI-Device Identifier: 30840143902646
• UDI-Public: (01)30840143902646(17)251201(10)126011
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/31/2023
• Report Date (Section F): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CRYO2
• Device Catalogue Number: A000683-6
• Device Lot Number: 126011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 90 KG
• Date Report Sent to FDA: 05/31/2023