MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE CRYOICE CRYOSPHERE+ CRYOABLATION SYSTEM; DEVICE, SURGICAL, CRYOGENIC

Model Number	CRYOSP-L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure the cryoablation machine was not working properly and according to the rep who was handling the machine, the issue was that the box would not completely defrost after the first use.It was rebooted and functioned properly.There was no patient harm.

• Brand Name: ATRICURE CRYOICE CRYOSPHERE+ CRYOABLATION SYSTEM
• Common Device Name: DEVICE, SURGICAL, CRYOGENIC
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 23412815
• Report Number: 23412815
• Device Sequence Number: 18737092
• Product Code: GXH
• UDI-Device Identifier: 30840143911730
• UDI-Public: (01)30840143911730(17)280501(10)153896C
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2025
• Report Date (Section F): 10/08/2025

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: CRYOSP-L
• Device Catalogue Number: A001448
• Device Lot Number: 153896C
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 95 KG
• Date Report Sent to FDA: 10/08/2025